Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection

Phase 1

Completed

• Conditions: HIV-1-infection; Gut Inflammation
• Interventions: Drug: Pentasa vs Align

• Registration Number: NCT03399903
• Lead Sponsor: AIDS Healthcare Foundation

Brief Summary

An open label study will be performed on 80 people with HIV infection who are maintained on effective treatment with antiretroviral drugs.

Detailed Description

The goal of this study is to test whether a bowel anti-inflammatory drug that is known to be safe and effective for inflammatory bowel disease would offer benefit in reducing the residual immune activation associated with treated HIV-1 infection. Specifically, the two immediate goals are to examine the safety of Pentasa® in reducing markers of immune activation believed to be important reflectors of risk for cardiovascular disease and ongoing immune damage in people with chronic treated HIV-1 infection.

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-17
• Primary Completion: 2019-03-22
• Study Completion: 2019-03-22
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Age at least 18
• On ART for at least 1 year during which: viremia <50 RNA copies/ml for at least 3 measurements (allowing for 1 nonconsecutive blip of <100), and CD4 T cell count consistently >500 during that time
• CD4 T cell nadir >350
• Last CD4 and T cell test in past 6 months

Exclusion Criteria

• Plans to modify antiretroviral therapy in the next 12 weeks for any reason
• History of inflammatory bowel disease or irritable bowel disease
• Chronic active hepatitis B or C
• History of autoimmune disease
• Hypersensitivity to any component of Pentasa
• Clostridium difficile infection
• Receiving rectally delivered medications
• Receiving anti-inflammatory medications (such as nonsteroidal anti- inflammatory drugs, steroids, or TNF inhibitors)
• Receiving immunosuppressive steroids
• Receiving any medications associated with bleeding risk
• Hemoglobin < 10.0 g/dL
• Platelet count less than 100,000/mm3
• White blood cell count < 2,000 cells/mm3 or > 15,000 cells/mm3
• Symptoms of sexually transmitted infection
• Antibiotics used in the last 90 days
• Renal insufficiency with creatinine clearance less than 50 ml/min
• Elevated transaminases greater than 2.5 times the upper limit of normal
• Evidence of decompensated cirrhosis, heart failure
• Pregnant or breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pentasa	Pentasa vs Align	40 participants will be randomized to take 1 gram of Pentasa, twice daily for 8 weeks
Align	Pentasa vs Align	40 participants will be randomized to take Align tablets, once daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Inflammation markers	14 weeks	C-reactive protein

Secondary Outcome Measures

Name	Time	Method
Plasma markers of microbial translocation	14 weeks	Microbial translocation
Flow cytometry for cellular immune activation	14 weeks	Immune activation

Trial Locations

Locations (1)

AIDS Healthcare Foundation - Public Health Division; 🇺🇸 Los Angeles, California, United States